Kornimate/medical-research-clean huggingface dataset:
erenumab - comprehensive assessment of efficacy in (high-frequency) episodic migraine

Conditions: Migraine

Summary: the primary objective of this study is to evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity.


Eligibility criteria:
key inclusion criteria include: * age greater than or equal to 18 years upon entry into initial screening. * documented history of migraine with or without aura according to the international headache society (ihs) international classification of headache disorders, third edition (ichd-iii) for greater than or equal to 12 months. * have high-frequency episodic migraine (hfem): defined as history of ≥ 7 to \< 15 migraine days and \< 15 headache days per month on average during the 3 months prior to screening. * history of ≥ 4 migraine attacks of at least moderate severity per month on average during the 3 months prior to screening. * history of treatment failure with at least 1 preventive treatment for migraine. failure of preventive treatment for migraine is defined as treatment discontinuation due to lack of efficacy, adverse event, or general poor tolerability. * regular use of an oral triptan (using only eletriptan, rizatriptan, sumatriptan, or zolmitriptan) for acute migraine treatment, and typically initiating acute treatment with an oral triptan on \> 50% of attacks of at least moderate pain intensity. regular use is defined as ≥ 4 days of oral triptan use per month during the 3 months prior to screening. key exclusion criteria include: * history of hemiplegic migraine, cluster headache, or other trigeminal autonomic cephalalgia. * has any medical contraindication to the use of an oral triptan. * previously treated with erenumab. * previously treated with a gepant (small molecule calcitonin gene related peptide receptor \[cgrp-r\] antagonist) in a preventive fashion in a manner consistent with migraine prevention that either: 1. in the opinion of the investigator, did not offer any evidence of a therapeutic response or 2. was discontinued for less than 12 weeks from the date of initial screening or 3. was previously discontinued due to a known adverse drug reaction * currently being treated with lasmiditan and/or a gepant in the acute setting. * no therapeutic response with greater than 4 of the defined medication categories after an adequate therapeutic trial. * currently has a history of consistent excellent response to oral triptans, defined as achievement of pain-freedom in ≤ 1 hour for ≥ 50% of treated attacks of at least moderate pain intensity during the 3 months prior to screening. * use of triptans administered via a non-oral (e.g. subcutaneous \[sc\] or intranasal delivery systems) or sublingual route at the time of screening, during the run-in and baseline periods, and throughout the study duration.
surfactant administration via thin catheter using a specially adapted video laryngoscope - the visual method

Conditions: Respiratory Distress Syndrome, Newborn

Summary: surfactant administration via thin catheter using a specially adapted video laryngoscope - a prospective, multicenter trial, assessing the feasibility of the visual method (video surfactant administration laryngoscopy). the study will search for the number of attempts until surfactant is administrated, assessment of the infants' stability during the procedure, duration of the entire procedure, form laryngoscope insertion to surfactant administration.

in this study the investigators intend to assess the feasibility of surfactant administration via a thin catheter using a specially adapted video laryngoscope, with a groove designed to allow insertion of an endovascular catheter without the use of other instruments in the oral cavity (forceps ect.). the laryngoscope is manufactured by peak medic ltd, natania, israel. primary endpoints 1. - number of attempts until surfactant is administrated 2. - assessment of the infants' stability during the procedure - saturation, bradycardia, tachycardia. 3. - duration of the entire procedure, form laryngoscope insertion to surfactants administration. 4. secondary endpoints 1. - need of invasive mechanical ventilation in the next 24 hours. 2. - complications reports 3. - subjective procedure scale of assessment 4. - unexpected pitfalls reports 5. - safety assessment of the procedure

Eligibility criteria:
inclusion criteria: 1. - premature infants with gestational age 30-36 weeks. 2. - diagnosis of respiratory distress syndrome 3. - spontaneously breathing with non-invasive positive pressure ventilation. 4. - maximal age 3 days. exclusion criteria: 1. - apgar score at 5 min \< 5 2. - need for chest compressions or medication upon delivery. 3. - evident major congenital malformation, metabolic or genetic disorders. 4. - clinical evidence of sepsis.

Keywords: respiratory distress syndrome videolaryngoscopy newborn infant premature newborn infant surfactant administration
to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of disitamab vedotin in patients with high-risk non-muscular invasive bladder cancer (nmibc) that express her2

Conditions: High-risk Non-muscle Invasive Bladder Cancer

Summary: the purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of disitamab vedotin in patients with high-risk non-muscular invasive bladder cancer (nmibc) that express her2

this is a single-arm, multicenter phase i/ii clinical study to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of disitamab vedotin in patients with high-risk non-muscular invasive bladder cancer (nmibc) that express her2.

Eligibility criteria:
inclusion criteria: 1. voluntary consent to participate in the study and signed the informed consent form. 2. male or female, age 18-75 years (including both). 3. histologic confirmed non-muscle invasive bladder urothelial carcinoma (nmibc), and the risk group met the high-risk (including very high-risk) group. note: high-risk nmibc is a high-grade / g3 tumor meeting any of the following: a.carcinoma in situ (cis) b. t1 stage c. diameter\>3cm d.multiple tumors, or recurrent tumors. 4. absence of resectable disease（ta and/or t1 disease） after transurethral resection (turbt) procedures (residual cis acceptable; 5. the urologist assessed that radical surgery for bladder cancer was not suitable or the subject refused radical surgery for bladder cancer. 6. tumor tissue samples were detected by immunohistochemistry (ihc) to satisfy her2 expression of 1+, 2+ or 3+. 7. eastern cooperative oncology group (ecog) performance status of 0-1. 8. adequate heart, bone marrow, liver, kidney and coagulation function exclusion criteria: * 1. invasive bladder cancer (t2 and above) and / or with regional lymph node and distant metastasis. 2. combined urothelial carcinoma outside the bladder (i. e., urethra, ureter or renal pelvis). 3. any other antitumor therapy received within 4 weeks before study administration, . 4 subjects plan to undergo major surgery during the study or within 4 weeks before the first dose. 5, known allergic to dv and its components or to any excipients.

Keywords: her2-expression high-risk non-muscle invasive bladder cancer intravesical instiliations
dose ranging study to assess the efficacy and safety of acitretin in severe plaque type psoriasis

Conditions: Psoriasis

Summary: in this study, the investigators will intend to compare the efficacy and safety of various doses of acitretin in a randomized double blind manner in patients with severe plaque-type psoriasis, by i) studying the change pasi score from baseline as a measure of efficacy ii) determining the frequency of side effects at various doses. sixty patients will be recruited from psoriasis clinic of department of dermatology, venerology and leprology, pgimer. patients will be randomly assigned to one of the three groups: group a, consisting of 20 patients, will be administered acitretin 25 mg/ day ,group b, consisting of 20 patients, will be administered acitretin 35 mg/day and group c consisting of 20 patients, will be administered acitretin 50 mg/day this therapy will be continued until psoriasis area and severity index (pasi) scores are reduced to \< 25% of the original scores or 12 weeks, whichever comes earlier. it is expected that acitretin at higher doses will be more efficacious . as the exact etiopathogenesis of psoriasis is not fully known, it is difficult to provide a definite cure to all patients, though the disease activity can be controlled to a great extent with various treatment modalities. however the dosage of acitretin be adjusted according to response of the patients and tolerability of side effects.


Eligibility criteria:
inclusion criteria: * patients with plaque-type psoriasis having \<90%of body surface area involvement, whose disease activity had been stable for the last 1month. * age range 18-65 years of either sex * females who are postmenopausal or tubectomised or have completed their family and are willing to maintain contraception 1 month before, during and 2 years after completion of treatment and negative pregnancy tests within 2 months of starting of treatment. * compliance for scheduled visit. exclusion criteria: * patients with severe hepatic, renal or other systemic disorders (serum bilirubin,ast,alt and alkaline phosphatase\>1.5 times upper limit of normal;serum creatinine \>1.5 mg% in males and \>1.4mg% in females) * pregnant or lactating women,contemplating pregnancy in next 2 -3 years * alcoholic * metabolic disorders such as hyperlipidemia * obese/bmi≥ 30 kg/m2 * ischemic heart diseases,neuropsychiatric illness

Keywords: psoriasis
a clinical study of pembrolizumab (+) berahyaluronidase alfa (mk-3475a) to treat newly-diagnosed metastatic non-small cell lung cancer (mk-3475a-f84)

Conditions: Lung Cancer; Non-Small Cell Lung Cancer

Summary: researchers are looking for new ways to treat non-small cell lung cancer (nsclc) that is metastatic, which means cancer has spread to other parts of the body. some people with metastatic nsclc are treated with pembrolizumab, an immunotherapy treatment that is given into a vein as an intravenous (iv) infusion. pembrolizumab (+) berahyaluronidase alfa is pembrolizumab that is given under the skin as a subcutaneous (sc) injection. the goal of this study is to compare what happens to pembrolizumab in a person's body over time when it is given as an iv infusion or sc injection.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (nsclc). * measurable disease as assessed by the local site investigator/radiology. exclusion criteria: * diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements. * received prior systemic anticancer therapy for their metastatic nsclc. * known additional malignancy that is progressing or has required active treatment within the past 3 years. * known active central nervous system (cns) metastases and/or carcinomatous meningitis. * active autoimmune disease that has required systemic treatment in the past 2 years. * history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * active infection requiring systemic therapy.
desflurane in children with laryngeal mask airway

Conditions: Desflurane Anesthesia

Summary: the purpose of this study is to characterize the airway responses to desflurane during maintenance of and emergence from anesthesia in children whose airways were supported with laryngeal mask airways (lmas).


Eligibility criteria:
inclusion criteria: * scheduled for elective surgery under general anesthesia with laryngeal mask airway exclusion criteria: * history of reactive airways disease with an acute exacerbation within the past 2 weeks * if wheezing or an active upper respiratory infection was present on the day of surgery * if there was a history of malignant hyperthermia * a history of moderate-to-severe hepatic dysfunction following anesthesia with desflurane not otherwise explained.
scleroderma lung: role of gastroesophageal reflux, microaspiration and cough

Conditions: Scleroderma Lung

Summary: this is a mechanistic research study to evaluate the relationship between cough, reflux, and aspiration in patients with systemic sclerosis (scleroderma).


Eligibility criteria:
inclusion criteria: * adult patients ≥ 18 years old. * fulfilling the american college of rheumatology criteria for ssc. * for ild subgroup (n=6): * an upright chest-roentgenogram (chest x-ray) is abnormal and compatible with an interstitial lung disease. * hrct of the chest confirms the presence of bilateral reticular, ground glass, and/or honeycomb abnormalities that is otherwise unexplained by an alternative process * the hrct fibrosis score must be ≥ 7. * the total lung capacity (tlc, measured by body plethysmography) and/or the diffusing capacity of the lung for carbon monoxide (dlco) is below the predicted normal. * the forced vital capacity (fvc) is reduced below the predicted normal. * the patient is symptomatic (i.e. dyspnea and/or a chronic cough) for more than 8 weeks that is otherwise unexplained by an alternative mechanism. * for no ild subgroup (n=6): * no radiographic evidence of ild on plain chest x-ray. * the hrct fibrosis score, when performed) must be \< 7 * the tlc and fvc are within their predicted normal. * the dlco is within the predicted normal, except when reduced in isolation by pulmonary hypertension. exclusion criteria: * active smoking within the 6 months. * pneumonia or bronchitis in past 4 weeks. * active acute illness such as uncontrolled heart failure, infection, or asthma. * use of more than 3 liters per minute (lpm) of oxygen by nasal cannula at rest. * coordinator, investigator, or clinician concerns on the patient's compliance, safety, or in ability to complete study requirements. * morbid condition not expected to live more than 1 year. * alternative cause or diagnosis for the patient's ild besides ssc. * pregnancy. * obstructive lung disease with an fev1 (forced expiratory volume in 1 second) to fvc ratio less than 0.7, nor radiographic evidence of emphysema on ct. * planned therapeutic procedures involving the esophagus (e.g. dilation, surgery) prior to completion of study tests

Keywords: scleroderma lung gastroesophageal reflux microaspiration cough
sentinel lymph node biopsy with or without para-sentinel lymph node dissection in breast cancer

Conditions: Breast Cancer

Summary: sentinel lymph node biopsy（slnb） is an established way of predicting axillary nodal metastasis in early breast cancer. we aim to determinethe，in a prospective randomized, controlled trial, effect of sentinel lymph node biopsy with para-sentinel lymph node(sln) dissection versus sentinel lymph node biopsy without para-sentinel lymph node dissection on outcomes after breast surgery.

aim: compare the disease-free survival (dfs) and overall survival (os) of breast cancer patients who are randomized to receive sentinel lymph node biopsy with para-sentinel lymph node dissection group vs. those receive only sentinel lymph node biopsy without para-sentinel lymph node dissection outline: patients are randomized assigned to the following one of two groups and are followed annually. arm i: patients receive sentinel lymph node biopsy with para-sentinel lymph node dissection arm ii: patients receive only sentinel lymph node biopsy without para-sentinel lymph node dissection

Eligibility criteria:
inclusion criteria: 1. histologically confirmed primary breast cancer by core needle biopsy or excisional biopsy 2. abnormal para-sentinel lymph node was found by ultrasound examination 3. ultrasound-guided fine needle aspiration cytology of these nodes were performed 4. the result of fine needle aspiration cytology was negative (no tumour cell was found) 5. patient planed to perform slnb exclusion criteria: 1. pathological diagnosed ductal carcinoma in situ by excisional biopsy 2. the result of fine needle aspiration cytology was positive 3. patient has received neo-adjuvant system therapy
alectinib versus pemetrexed or docetaxel in anaplastic lymphoma kinase (alk)-positive advanced non-small cell lung cancer (nsclc) participants previously treated with platinum-based chemotherapy and crizotinib

Conditions: Non-small Cell Lung Cancer

Summary: this randomized active-controlled multicenter phase iii open-label study will evaluate and compare between treatment groups the efficacy of alectinib versus chemotherapy in participants with alk-positive advanced nsclc who were previously treated with chemotherapy and crizotinib, as measured by investigator-assessed progression-free survival (pfs) and to evaluate and compare between treatment groups the central nervous system (cns) objective response rate (c-orr) in participants with measurable cns metastases at baseline, as assessed by an independent review committee (irc).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of advanced or recurrent (stage iiib not amenable for multimodality treatment) or metastatic (stage iv) nsclc that is alk-positive. alk positivity must have been determined by a validated fluorescence in situ hybridization (fish) test (recommended probe, vysis alk break-apart probe) or a validated immunohistochemistry (ihc) test (recommended antibody, clone d5f3) * participant had received two prior systemic lines of therapy, which must have included one line of platinum-based chemotherapy and one line of crizotinib * prior cns or leptomeningeal metastases allowed if asymptomatic * participants with symptomatic cns metastases for whom radiotherapy is not an option will be allowed to participate in this study * measurable disease by recist version 1.1 prior to the administration of study treatment * eastern cooperative oncology group (ecog) performance status of 0-2 * for all females of childbearing potential, a negative pregnancy test must be obtained within 3 days before starting study treatment exclusion criteria: * participants with a previous malignancy within the past 3 years are excluded (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal \[gi\] cancer by endoscopic resection or in situ carcinoma of the cervix) * participants who have received any previous alk inhibitor other than crizotinib * any gi disorder that may affect absorption of oral medications
the effects of coenzyme a combined with statin on serum lipids in patients with hyperlipidemia

Conditions: Hyperlipoproteinemia

Summary: the purpose of this study is to evaluate the lipid lowering effects and clinical safety of a natural hypolipidemic compound, coenzyme a （coa） capsule, combined use with statin, in chinese patients with moderate dyslipidemia.

although lowering cholesterol and low-density lipoprotein-cholesterol (ldl-c) is the mainstay of medical therapy for cardiovascular event prevention, evidence from clinical trials supports a role for elevated triglyceride (tg) and low high-density lipoprotein cholesterol (hdl-c) concentrations in the residual cardiovascular risk on statin treatment. fenofibrate is the most commonly used agent to control hypertriglyceridemia as monotherapy or combining with statin, which lowers tg and raises hdl-c through multifaceted mechanism by pparα activation. however, safety of coadministration of statin with fenofibrate has been a great concern, especially drug-induced hepatotoxicity when they are combined used. coenzyme a (coa) functions as an acyl group carrier and assists in transferring fatty acids from the cytoplasm to mitochondria. it is also involved in the oxidation and catabolism of fatty acids. animal studies have proved its lipid-lowering effects. in a previous multicenter study we conducted in 2008, it was found that oral coa 400u/d effectively lowered serum tg levels in hypertriglyceridemia patients without increasing adverse effects when compared with placebo. so, the present study was performed to further investigate the lipid-lowing effects and safety of coa capsule combined with statin in dyslipidemia patients.

Eligibility criteria:
inclusion criteria: * tg 2.3～7.0mmol/l * 18-80 years of age * combined use with statins exclusion criteria: * pregnancy * acute liver disease or hepatic dysfunction, as determined by levels of alanine aminotransferase (alt) or aspartate aminotransferase levels (ast) more than 2-fold the upper normal limit * nephrotic syndrome or serum creatinine (cr) ≥2-fold the upper normal limit and creatine phosphokinase (ck) more than 3-fold the upper normal limit * primary hypothyroidism * psychiatric patients * poorly controlled hypertension, as indicated by a systolic blood pressure \>180 mmhg or diastolic blood pressure \>110 mmhg * using contraceptive agent * using immunosuppressive drugs, prohibited medication or other non-statin lipid-lowing drugs
evaluation of drug's risk in pregnant women

Conditions: Pregnancy

Summary: medication during pregnancy can lead to the occurrence of birth defects or neonatal pathologies. thalidomide or diethylstilbestrol (distilbene°) are prominent examples. many drugs remain insufficiently evaluated in this area and doctors are too often deprived of relevant information when prescribing drugs in pregnant women.

to fill this gap, the investigators have put in place since 2004, a database, efemeris, recording products given to women during pregnancy in haute-garonne (data from primary health insurance fund), fate of these pregnancies and the state health of newborns (mother and child protection data, prenatal diagnostic centre and medicalisation program of information systems data). women included in this database (\> 90 000 to date) has allowed us to study the risks of taking certain medications still not assessed in pregnant women (for example phloroglucinol, the h1n1 flu vaccine , oseltamivir ...). each year about 10 000 pregnant women join the cohort. the collection and management of data concerning require careful organization and mobilize multiple stakeholders. the pursuit of these inclusions is needed to study medication less often prescribed but raise questions. for example, if the investigators consider that the relative risk of cardiac abnormalities following in utero exposure to paroxetine is multiplied by 1.5, it will take 1,000 women exposed to paroxetine for 5 additional cases observed. in december 2013, 0.3% of women efemeris were exposed to paroxetine in the first quarter (274 women). the objective of this project is to continue the efemeris project (funded for 10 years public tenders until december 2015) by continuing to include pregnant women (about 10 000 per year) in order to explore the potential effects of exposure to different drugs on the newborn (prematurity, birth defects, neonatal diseases). the processing of data will efemeris to detect drugs at risk to the fetus and provide a warning role in terms of malformation effects, to monitor over time prescribing practices, participate in pharmacoepidemiology international multicenter studies including similar databases in general population.

Eligibility criteria:
inclusion criteria: * women supported by the general scheme of the primary health insurance fund of the haute-garonne who gave birth or had a miscarriage between 1 january 2015 and 31 december 2017. * women not opposing that us to access to their data. * women for which at least one baby health certificate has been registered at the mother and child protection, or the outcome of pregnancy was identified by prenatal diagnosis center or medicalisation program of information systems. exclusion criteria: * women that refuses to give access to the data concerning them. * women for which no data on pregnancy outcome can be collected.

Keywords: database birth defects neonatal pathologies